FDA Grants Priority Review to Ocrevus in MS

The FDA has set a target action date of December 28, 2016

Genentech announced that the Food and Drug Administration (FDA) has accepted and granted Priority Review to the Biologics License Application (BLA) for Ocrevus (ocrelizumab) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).

The BLA submission is supported by positive data from three randomized, double-blind, global multicenter, Phase 3 studies evaluating Ocrevus in patients with RMS (OPERA I and OPERA II) and in patients with PPMS (ORATORIO). All three studies met their primary and key secondary endpoints, demonstrating the superior efficacy of Ocrevus in reducing annualized relapse rates and disability progression sustained for at least three and for at least six months vs. Rebif (interferon beta-1a) or placebo.